Aseptic Processing & Annex 1 Training Course

Aseptic Processing & Annex 1 (T63)

Level: Fundamental, Intermediate and Advanced
ISPE CEUs: 1.3
Duration: 2 days, 15 content hours
Type: Classroom Training Course

Driven by biopharmaceuticals but also prominent in small molecules drug manufacturing as well as for APIs, aseptic processing will undergo a technology jump start driven by the new EC GMP Guide Annex 1. Globally supplying companies, which deliver drugs to Europe, must comply with this new regulatory requirement. There is an impact for all stakeholders of manufacturing, across hierarchy levels and various functions at manufacturers. Also, suppliers have to consider Annex 1 when supplying new equipment or installing new production facilities. This 2-day course will focus on aseptic processing and quality management around the most important pharmaceutical technology.

Supporting Documents:

  • EC GMP Guide Annex 1, 2018
  • FDA CFR 210 and 211

Course Modules

  • Module 1 Introduction to the Regulatory Framework
  • Module 2 Hot Topics from Annex 1 Draft
  • Module 3 Interaction of Process and Aseptic Fill/Finish Operations
  • Module 4 Principles of Aseptic Processing
  • Module 5 Process Development and Validation
  • Module 6 Quality Risk Management
  • Module 7 Training Systems
  • Module 8 Interactive Session/Case-Based Learning
  • Module 9 How to Prepare for Regulatory Inspections

Take Back to Your Job

  • Upon completing this course, you will be able to:
  • Understand the new EC GMP Guide Annex 1 and its impact on future aseptic processing
  • Determine the current industry standards for manufacturing and environmental control
  • Engage in critical topics discussion in regulators inspections

Who Should Attend

  • Managers of production and quality assurance
  • Process engineers
  • Engineers responsible for infrastructure and maintenance
  • Quality managers
  • Shop floor supervisors
  • Middle management
  • Department heads
  • Suppliers for equipment and infrastructure of aseptic manufacturing plants
This course is not currently scheduled, but may be offered at your company site. Please contact ISPE for more information